General information

Marketing authorisation holders who are obliged to stockpile proprietary medicinal products on the basis of a prescription pursuant to Section 57a para. 2 AMG are entitled to compensation for the additional costs incurred as a result pursuant to Section 94k AMG upon application to the BASG. The additional costs are only those costs that exceed the costs incurred for normal stockpiling (to cover the needs of patients in Austria).

Calculation of the compensation to be claimed

Of the additional costs, those for storage amounting to a maximum of 5% of the ex-factory price per pharmaceutical speciality to be stockpiled (patient requirements for 4 months as stated in the notification of requirements to be submitted to the BASG) and costs amounting to the 3-month EURIBOR rate plus 0.25 percentage points, calculated on the ex-factory price per pharmaceutical speciality to be stockpiled, will be reimbursed. 

3-month EURIBOR according to (https://www.euribor-rates.eu/):

The reference date for the EURIBOR 3-month rate is 1 January of the year in which the application is submitted (for applications relating to the previous calendar year). The demand report received by the BASG is checked for plausibility on the basis of the available sales data for the Austrian market in the previous calendar year; minor fluctuations can be accepted.

Types of costs

The costs of the usual stockpiling to cover the needs of patients in Austria are calculated on the basis of the average stockpiled medicinal specialities in the years 2022 to 2024 (period before the regulation came into force). This is based on the assumption of usual rolling stockholding to such an extent that the patient's needs can be covered for a period of three months. If a lower quantity of the usual stockpile (than is required to cover the three-month requirement) is specified when submitting the application, this may result in a longer processing time for your application due to the increased testing requirements in these cases.

The storage costs and costs for the usual stockpiling used to calculate the additional costs must be itemised separately when submitting the application and confirmed by an independent auditor. Confirmation from the respective independent auditor regarding the economic viability of the stockpiling carried out is also required.

Application

When submitting an application, the BASG must be provided with all evidence on which the confirmation by an independent auditor was based, as well as the monthly stock levels of the stockpiled medicinal specialities. The evidence regarding the monthly stock level must be submitted for comparability (and to verify the information on usual stockpiling) from January 2022 until the time of application.

The application can be submitted using the following web form: 

Link to the web form: 

Application pursuant to Section 94k of the Medicines Act for compensation for the additional costs of stockpiling medicines: BASG - TForms

Please fill in the following fields:

• Name of the marketing authorisation holder
• Address of the marketing authorisation holder
• Contact details of the marketing authorisation holder
• ORG-ID and LOC-ID of the marketing authorisation holder (in accordance with spor.ema.europa.eu) – if available
• Storage costs
• Capital commitment costs (costs for normal stockpiling)
• IBAN
• BIC
• Proof of cost calculation: - Please use and upload the following Excel file for this purpose.
• Confirmation from an independent auditor, including all supporting documents, must be uploaded in PDF format
• Confirmation that the form has been completed correctly

The BASG reserves the right to make further additions to the specifications in question should the need arise on the basis of the demand reports received or applications for reimbursement of costs.

Payment of the requested compensation for additional costs:

After the application has been submitted, the documents will be reviewed by the BASG. The funds will be paid out quarterly to the account you have specified.